Effectiveness and safety of oral terbinafine for dermatophyte distal subungual onychomycosis

References

• Krishnan-Natesan S. Terbinafine: a pharmacological and clinical review. Expert Opin Pharmacother. 2009;10:2723–2733. doi: 10.1517/14656560903307462
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. LAMISIL ® (terbinafine hydrochloride) tablets, for oral use. 2019.
   Google Scholar
• Gupta AK, Venkataraman M, Bamimore MA. Relative impact of traditional vs. newer oral antifungals for dermatophyte toenail onychomycosis: a network meta-analysis study. Br J Dermatol. 2023;189:12–22. doi: 10.1093/bjd/ljad070
   PubMed Web of Science ®Google Scholar
• Ricardo JW, Lipner SR. Safety of current therapies for onychomycosis. Expert Opin Drug Saf. 2020;19(11):1395–1408.
   PubMed Web of Science ®Google Scholar
• Lopes AI, Tavaria FK, Pintado ME. Conventional and natural compounds for the treatment of dermatophytosis. Med Mycol. 2020;58:707–720. doi: 10.1093/MMY/MYZ116
   PubMed Web of Science ®Google Scholar
• Gupta AK, Foley KA, Versteeg SG. New antifungal agents and new formulations against dermatophytes. Mycopathologia. 2017;182:127–141. doi: 10.1007/S11046-016-0045-0
   PubMed Web of Science ®Google Scholar
• Shen JJ, Arendrup MC, Verma S, et al. The emerging terbinafine-resistant trichophyton epidemic: what is the role of antifungal susceptibility testing? Dermatology. 2022;238:60–79. doi: 10.1159/000515290
   PubMed Web of Science ®Google Scholar
• Jabet A, Normand AC, Brun S, et al. Trichophyton indotineae, from epidemiology to therapeutic. J Mycol Med. 2023;33(3):33.
   Web of Science ®Google Scholar
• Gupta AK, Taborda PR, Sanzovo AD. Alternate week and combination itraconazole and terbinafine therapy for chromoblastomycosis caused by Fonsecaea pedrosoi in Brazil. Med Mycol. 2002;40(5):529–534. doi: 10.1080/MMY.40.5.529.534
   PubMed Web of Science ®Google Scholar
• Gupta AK, Summerbell RC, Venkataraman M, et al. Nondermatophyte mould onychomycosis. J Eur Acad Dermatol Venereol. 2021;35(8):1628–1641. doi: 10.1111/JDV.17240
   PubMedGoogle Scholar
• Sacheli R, Hayette MP. Antifungal resistance in dermatophytes: genetic considerations, clinical presentations and alternative therapies. J Fungi. 2021;7(11):983. doi: 10.3390/JOF7110983
   Web of Science ®Google Scholar
• Jabet A, Brun S, Normand AC, et al. Extensive dermatophytosis caused by Terbinafine-Resistant Trichophyton indotineae, France. Emerg Infect Dis. 2022;28:229–233. doi: 10.3201/EID2801.210883
   PubMed Web of Science ®Google Scholar
• Los Rios CJ P-D, Tadros E, Summerbell RC, et al. Terbinafine resistant trichophyton indotineae isolated in patients with superficial dermatophyte infection in Canadian patients. J Cutan Med Surg. 2022;26(4):371–376. doi: 10.1177/12034754221077891
   PubMed Web of Science ®Google Scholar
• Messina F, Santiso G, Romero M, et al. First case report of tinea corporis caused by Trichophyton indotineae in Latin America. Med Mycol Case Rep. 2023;41:48–51. doi: 10.1016/J.MMCR.2023.08.004
   PubMed Web of Science ®Google Scholar
• Cañete-Gibas CF, Mele J, Patterson HP, et al. Terbinafine-resistant dermatophytes and the presence of trichophyton indotineae in North America. J Clin Microbiol. 2023;61:e0056223. doi: 10.1128/JCM.00562-23
   PubMed Web of Science ®Google Scholar
• Uhrlaß S, Verma SB, Gräser Y, et al. Trichophyton indotineae—an emerging pathogen causing recalcitrant dermatophytoses in India and worldwide—a multidimensional perspective. J Fungi. 2022;8(7):8.
   Web of Science ®Google Scholar
• Canada H. LAMISIL® (Terbinafine Hydrochloride) Product Monograph. 2022.
   Google Scholar
• European Medicines Agency. Lamisil tablets 250mg. 2020.
   Google Scholar
• Gupta AK, Stec N, Bamimore MA, et al. The efficacy and safety of pulse vs. continuous therapy for dermatophyte toenail onychomycosis. J Eur Acad Dermatol Venereol. 2020;34(3):580–588. doi: 10.1111/jdv.16101
   PubMed Web of Science ®Google Scholar
• Pavlotsky F, Armoni G, Shemer A, et al. Pulsed versus continuous terbinafine dosing in the treatment of dermatophyte onychomycosis. J Dermatolog Treat. 2004;15(5):315–320. doi: 10.1080/09546630410018076
   PubMedGoogle Scholar
• Saleem MA, Shah RR, Sharif S, et al. Comparing the efficacy for pulse versus continuous dose terbinafine therapy in patients with onychomycosis. J Drugs Dermatol. 2023;22:1017–1020. doi: 10.36849/JDD.7323
   PubMedGoogle Scholar
• Finlay AY. Pharmacokinetics of terbinafine in the nail. Br J Dermatol. 1992;126(s39):28–32. doi: 10.1111/j.1365-2133.1992.tb00006.x
   PubMedGoogle Scholar
• Schatz F, Brautigam M, Dobrowolski E, et al. Nail incorporation kinetics of terbinafine in onychomycosis patients. Clin Exp Dermatol. 1995;20:377–383. doi: 10.1111/j.1365-2230.1995.tb01353.x
   PubMed Web of Science ®Google Scholar
• Brautigam M, Nolting S, Schopf RE, et al. Randomised double blind comparison of terbinafine and itraconazole for treatment of toenail tinea infection. Seventh Lamisil German Onychomycosis Study Group. BMJ. 1995;311:919. doi: 10.1136/BMJ.311.7010.919
   PubMed Web of Science ®Google Scholar
• Debruyne D, Coquerel A. Pharmacokinetics of antifungal agents in onychomycoses. Clin Pharmacokinet. 2001;40:441–472. doi: 10.2165/00003088-200140060-00005
   PubMed Web of Science ®Google Scholar
• Cribier BJ, Bakshi R. Terbinafine in the treatment of onychomycosis: a review of its efficacy in high-risk populations and in patients with nondermatophyte infections. Br J Dermatol. 2004;150(3):414–420.
   PubMed Web of Science ®Google Scholar
• Nandwani R, Parnell A, Youle M, et al. Use of terbinafine in HIV-positive subjects: pilot studies in onychomycosis and oral candidiasis. Br J Dermatol. 1996;134(Suppl 46):22–24. doi: 10.1111/J.1365-2133.1996.TB15655.X
   PubMedGoogle Scholar
• Herranz P, García J, De Lucas R, et al. Toenail onychomycosis in patients with acquired immune deficiency syndrome: treatment with terbinafine. Br J Dermatol. 1997;137:577–580. doi: 10.1111/J.1365-2133.1997.TB03789.X
   PubMed Web of Science ®Google Scholar
• Jensen P, Lehne G, Fauchald P, et al. Effect of oral terbinafine treatment on cyclosporin pharmacokinetics in organ transplant recipients with dermatophyte nail infection. Acta Derm Venereol. 1996;76(4):280–281. doi: 10.2340/0001555576280281
   PubMed Web of Science ®Google Scholar
• Moreno-Sabater A, Ouali N, Chasset F, et al. Severe onychomycosis management with oral terbinafine in a kidney transplantation setting: clinical follow-up by image analysis. Mycoses. 2021;64(3):309–315.
   PubMed Web of Science ®Google Scholar
• Farkas B, Paul C, Dobozy A, et al. Terbinafine (lamisil) treatment of toenail onychomycosis in patients with insulin-dependent and non-insulin-dependent diabetes mellitus: a multicentre trial. Br J Dermatol. 2002;146(2):254–260. doi: 10.1046/J.1365-2133.2002.04606.X
   PubMed Web of Science ®Google Scholar
• Gupta AK, Gover MD, Lynde CW. Pulse itraconazole vs. continuous terbinafine for the treatment of dermatophyte toenail onychomycosis in patients with diabetes mellitus. J Eur Acad Dermatol Venereol. 2006;20(10):1188–1193. doi: 10.1111/J.1468-3083.2006.01698.X
   PubMed Web of Science ®Google Scholar
• Kramer ON, Albrecht J. Clinical presentation of terbinafine-induced severe liver injury and the value of laboratory monitoring: a Critically Appraised Topic. Br J Dermatol. 2017;177(5):1279–1284.
   PubMed Web of Science ®Google Scholar
• Sun CW, Hsu S. Terbinafine: safety profile and monitoring in treatment of dermatophyte infections. Dermatol Ther. 2019;32(6):32. doi: 10.1111/dth.13111
   Web of Science ®Google Scholar
• Gupta AK, Katz HI, Shear NH. Drug interactions with itraconazole, fluconazole, and terbinafine and their management. J Am Acad Dermatol. 1999;41:237–249. doi: 10.1016/S0190-9622(99)70055-1
   PubMed Web of Science ®Google Scholar
• Gupta AK, Ross GS. Interaction between terbinafine and warfarin. Dermatology. 1998;196:266–267. doi: 10.1159/000017890
   PubMed Web of Science ®Google Scholar
• Warwick JA, Corrall RJ. Serious interaction between warfarin and oral terbinafine. BMJ. 1998;316(7129):440–440. doi: 10.1136/BMJ.316.7129.440
   PubMedGoogle Scholar
• Kaushal M, Tolani P, Kumar N, et al. Terbinafine-induced liver injury. Natl Med J India. 2017;30(6):321–323. doi: 10.4103/0970-258X.239071
   PubMed Web of Science ®Google Scholar
• Ley D, Musto J, Said A. A case of progressive cholestatic drug-induced liver injury due to terbinafine. WMJ. 2023;122(2):138–142.
   PubMedGoogle Scholar
• García Rodrǐguez LA, Duque A, Castellsague J, et al. A cohort study on the risk of acute liver injury among users of ketoconazole and other antifungal drugs. Brit J Clinical Pharma. 1999;48(6):847–852. doi: 10.1046/J.1365-2125.1999.00095.X
   PubMed Web of Science ®Google Scholar
• Wang Y, Lipner SR. Retrospective analysis of laboratory abnormalities in patients with preexisting liver and hematologic diseases prescribed terbinafine for onychomycosis. J Am Acad Dermatol. 2021;84:220–221. doi: 10.1016/J.JAAD.2020.09.004
   PubMed Web of Science ®Google Scholar
• European Medical Agency. Package leaflet: information for the patient lamisil ® 250 mg tablets terbinafine. 2021.
   Google Scholar
• Elewski B, Tavakkol A. Safety and tolerability of oral antifungal agents in the treatment of fungal nail disease: a proven reality. Ther Clin Risk Manag. 2005;1(4):299–306.
   PubMedGoogle Scholar
• Etgü F. Retrospective analysis of liver enzyme abnormalities in patients prescribed terbinafine and itraconazole for onychomycosis. Cureus. 2023;15:e44914. doi: 10.7759/CUREUS.44914
   PubMed Web of Science ®Google Scholar
• Lee MS, Lau AKW, Crosland G, et al. Renal impairment associated with oral terbinafine. Br J Dermatol. 1996;134:374–375. doi: 10.1111/J.1365-2133.1996.TB07638.X
   PubMed Web of Science ®Google Scholar
• Gupta AK, Soori GS, Del Rosso JQ, et al. Severe neutropenia associated with oral terbinafine therapy. J Am Acad Dermatol. 1998;38:765–767. doi: 10.1016/S0190-9622(98)70208-7
   PubMed Web of Science ®Google Scholar
• Kovacs MJ, Alshammari S, Guenther L, et al. Neutropenia and pancytopenia associated with oral terbinafine. J Am Acad Dermatol. 1994;31:806. doi: 10.1016/S0190-9622(09)80049-2
   PubMed Web of Science ®Google Scholar
• Tuccori M, Lapi F, Testi A, et al. Drug-induced taste and smell alterations: a case non-case evaluation of an Italian database of spontaneous adverse drug reaction reporting. Drug Saf. 2011;34(10):849–859.
   PubMed Web of Science ®Google Scholar
• Duxbury AJ, Oliver RJ, Pemberton MN. Persistent impairment of taste associated with terbinafine. Br Dent J. 2000;188(6):295–296. doi: 10.1038/sj.bdj.4800461a
   PubMed Web of Science ®Google Scholar
• Stricker BHC, Van Riemsdijk MM, Sturkenboom MCJM, et al. Taste loss to terbinafine: a case-control study of potential risk factors. Br J Clin Pharmacol. 1996;42:313–318. doi: 10.1046/J.1365-2125.1996.04105.X
   PubMed Web of Science ®Google Scholar
• Gupta AK, Gonder JR, Shear NH, et al. The development of green vision in association with terbinafine therapy. Arch Dermatol. 1996;132(7):845–846. doi: 10.1001/ARCHDERM.132.7.845
   PubMedGoogle Scholar
• Cohen PR, Erickson CP, Calame A. Terbinafine-induced lichenoid drug eruption: Case report and review of terbinafine-associated cutaneous adverse events. Dermatol Online J. 2020;26:4–5. doi: 10.5070/D3267049554
   Google Scholar
• Gupta AK, Lynde CW, Lauzon GJ, et al. Cutaneous adverse effects associated with terbinafine therapy: 10 case reports and a review of the literature. Br J Dermatol. 1998;138(3):529–532.
   PubMed Web of Science ®Google Scholar
• Zheng Y, Zhang J, Chen H, et al. Terbinafine-induced lichenoid drug eruption. Cutan Ocul Toxicol. 2017;36(1):101–103. doi: 10.3109/15569527.2016.1160101
   PubMed Web of Science ®Google Scholar
• Andersson NW, Thomsen SF, Andersen JT. Evaluation of association between oral and topical terbinafine use in pregnancy and risk of major malformations and spontaneous abortion. JAMA Dermatol. 2020;156(4):375–383. doi: 10.1001/JAMADERMATOL.2020.0142
   PubMed Web of Science ®Google Scholar
• Fávero MLD, Bonetti AF, Domingos EL, et al. Oral antifungal therapies for toenail onychomycosis: a systematic review with network meta-analysis toenail mycosis: network meta-analysis. J DermatolTreat. 2022;33:121–130. doi: 10.1080/09546634.2020.1729336
   Google Scholar
• Brydges HT, Onuh OC, Nasr HY, et al. Terbinafine induced pancreatitis in a healthy young adult male. Dermatol Ther. 2022;35:e15604. doi: 10.1111/DTH.15604
   PubMed Web of Science ®Google Scholar
• Gupta AK, Polla Ravi S, Wang T, et al. Antifungal resistance, susceptibility testing and treatment of recalcitrant dermatophytosis caused by trichophyton indotineae: a North American perspective on management. Am J Clin Dermatol. 2023 24;24(6):927–938. doi: 10.1007/S40257-023-00811-6
   PubMed Web of Science ®Google Scholar
• Gupta AK, Haas-Neill S, Talukder M. The safety of oral antifungals for the treatment of onychomycosis. Expert Opin Drug Saf. 2023;22(12):1169–1178. doi: 10.1080/14740338.2023.2280137
   PubMed Web of Science ®Google Scholar
• Bueno JG, Martinez C, Zapata B, et al. In vitro activity of fluconazole, itraconazole, voriconazole and terbinafine against fungi causing onychomycosis. Clin Exp Dermatol. 2009;35(6):658–663. doi: 10.1111/J.1365-2230.2009.03698.X
   PubMed Web of Science ®Google Scholar
• Falotico JM, Lipner SR. Updated perspectives on the diagnosis and management of onychomycosis. Clin Cosmet Investig Dermatol. 2022;15:1933–1957. doi: 10.2147/CCID.S362635
   PubMed Web of Science ®Google Scholar
• Gupta AK, Stec N, Summerbell RC, et al. Onychomycosis: a review. J Eur Acad Dermatol Venereol. 2020;34(9):1972–1990.
   PubMed Web of Science ®Google Scholar
• Drake LA, Shear NH, Arlette JP, et al. Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial. J Am Acad Dermatol. 1997;37(5):740–745. doi: 10.1016/S0190-9622(97)70111-7
   PubMed Web of Science ®Google Scholar
• Svejgaard EL, Brandrup F, Kragballe K, et al. Oral terbinafine in toenail dermatophytosis. A double-blind, placebo-controlled multicenter study with 12 months’ follow-up. Acta Derm Venereol. 1997;77(1):66–69. doi: 10.2340/0001555555776669
   PubMed Web of Science ®Google Scholar
• Faergemann J, Anderson C, Hersle K, et al. Double-blind, parallel-group comparison of terbinafine and griseofulvin in the treatment of toenail onychomycosis. J Am Acad Dermatol. 1995;32(5):750–753. doi: 10.1016/0190-9622(95)91454-4
   PubMed Web of Science ®Google Scholar
• Hofmann H, Bräutigam H, Weidinger G, et al. Treatment of toenail treatment of toenail onychomycosis. A randomized, double-blind study with terbinafine and griseofulvin. LAGOS II study group. Arch Dermatol. 1995;131(8):919–922. doi: 10.1001/archderm.131.8.919
   PubMedGoogle Scholar
• Takano M. Pharmacokinetics and pharmacodynamics: where are they going? Drug Metab Pharmacokinet. 2008;23:85–86. doi: 10.2133/DMPK.23.85
   PubMed Web of Science ®Google Scholar